Warming and nonirritating lubricant compositions and method of comparing irritation

ABSTRACT

This invention relates to substantially anhydrous warming, non-toxic and nonirritating lubricating compositions containing polyhydric alcohols and an insulating agent. The invention also relates to methods of using such compositions for lubrication, administration of active ingredients and for preventing or treating dysmenorrhea.

FIELD OF THE INVENTION

This invention relates to personal lubricant compositions that arewarming and nonirritating when applied to the skin or mucous membranes,especially the vaginal or oral mucosa. The compositions of thisinvention are substantially anhydrous and contain one or more polyhydricalcohol. This invention also relates to the method that can be used totest and compare the irritation of the compositions of this inventionand other personal lubricants known to the art.

BACKGROUND OF THE INVENTION

In the field of personal lubricants and medicaments applied to mucosalmembranes, from time to time attempts have been made to overcome theproblem of the perception of cold. When an individual applies personallubricant or medicament such compositions to internal mucosal membranes,often an individual experiences an uncomfortable, cold feeling due tothe difference in temperature between the body and the ambienttemperature.

An appreciable number of personal lubricant compositions are known tothe art. These compositions range from jellies to liquids to vaginalsuppositories and vary from being aqueous to oils to silicone based. Themajority of the compositions actually used today are aqueous jellies oraqueous liquids. Almost all personal lubricants known and available foruse today are cold to touch, a feeling that can be uncomfortable.

A number of compositions are known to the trade or described in theliterature that claim to impart a warming sensation upon application tothe skin or mucosa. Some of these compositions use plant extracts whichare irritating to the skin and mucous membranes and give a feeling orperception of warmth by virtue of their irritant action. Others claim toenhance blood flow in order to cause tissue warming. Still others arealleged to work on the principle of freezing point depression and arewell suited for heating in a microwave or cooling in a refrigerator.There is one cosmetic composition rendered self-heating by inclusion ofcompound containing a boron-to-boron linkage, which reacts exothermallywith water.

One example of a composition known to the trade, Prosensual™,distributed by Lexie Trading, Inc., Fairlaw, N.J., contains plantextracts such as Cinnamon cassia (Cinnamon), Zingiber officinalis(Ginger), Mint, Sandalwood, Orange and Clove, which are all known to beskin irritants. Such a composition has the disadvantage of causingirritation to the mucosa, which can be problematic in relation to thevaginal or oral mucosa as irritation may promote the growth of unwantedbacteria and cause infection.

Another current composition, WET™ Heating Massage Oil, distributed byInternational, Valencia, Calif., uses Retinyl Palmitate (Vitamin APalmitate), Prunus amygdalis (Prunes), Amara (Almond), Persicagratissima (Avacado Oil), Macdamia ternifulia Seed Oil, Kakeri Nut Oil,Helianthus annus (hybrid Sunflower), Cannabis sativa (Hemp) Seed Oil andAloe vera. Most of these ingredients are known irritants that are notsuitable for use on mucous membranes.

U.S. Pat. No. 5,895,658, entitled “Delivery of L-Arginine to CauseTissue Warming, Sustained Release of Nitric Oxide to treat effects ofDiabetes, Stimulate Hair Growth and Heal Wounds,” describes apreparation for producing enhanced blood flow in tissues thus causingbeneficial effects, such as warming cold tissues of hands and feet.

U.S. Pat. No. 5,513,629 entitled “Microwavable Heat Releasing andAbsorbing Compositions and Container, Pliable Gel Comprising Humectant,Freezing Point Depressant, Gel Sealer, Polyacrylamide Absorbent, CornStarch Binder, Mineral Oil and Plasticizers, Durability, Efficacy”describes compositions that have a high vapor points and are, therefore,suited for heating in a microwave oven or cooling in a freezer andplacement in a suitable container or vinyl package, such as ahot-and-cold pack, but not for human consumption or use.

However, none of the foregoing compositions are actually “warm”, or at arelatively higher temperature than the ambient temperature of theproduct or the surrounding environment.

U.S. Pat. No. 4,110,426, entitled “Method of Treating Skin and Hair witha Self Heated Cosmetic, Organic Boron-Oxygen-Boron Compounds” describesnon-aqueous compositions such as shaving creams, that are renderedself-heating by including therein a compound containing at least oneboron-oxygen-boron linkage, such as triethoxyboroxine. Theboron-containing compound reacts exothermally with water or other proticmaterial to increase temperature. Such compositions are not suitable forvaginal or oral use due to the potential toxicity of boron-containingcompounds to the human reproductive system (Fail P A, et al., general,reproductive, developmental, and endocrine toxicity of boronatedcompounds, Reprod toxicol 12: 1, 1-18, January-February, 1998).

Physical energy forms have been utilized to enhance material transportacross a membrane for therapeutic purposes. Such energy forms includeelectricity, ultrasound and thermal energy (e.g., heat-assisted drugdelivery), (reviewed by Sun, in “Skin Absorption Enhancement by PhysicalMeans: Heat, Ultrasound, and Electricity”, Transdermal and Topical DrugDelivery Systems, Interpharm Press, Inc., 1997, pages 327-355). Localheating of a drug delivery system or formulation, as well as the skin ormucosal tissues, not only increases thermodynamic energy of drugmolecules and membrane permeability to facilitate drug movement across abarrier membrane, it improves blood circulation in the tissue toexpedite drug removal from the local tissue into the systemiccirculation. Both processes leads to an enhanced absorption of the drug.Experimental evidence demonstrates that low-level heating (i.e., atissue temperature of less than about 42° C.) significantly enhancespercutaneous drug absorption.

U.S. Pat. No. 5,658,583 describes a heat-generating apparatus forimproved dermal permeation of pharmaceuticals. The apparatus includes athin drug formulation reservoir and a heat-generating chamber ofoxidation reaction separated by a non-permeable wall. The drugformulation reservoir houses a predetermined amount of a formulationcontaining pharmaceutical agents. Theheat-generating/temperature-regulating chamber includes aheat-generating medium consisting of carbon, iron, water and/or saltwhich is activated upon contact with oxygen in the air. However, acomplicated heating device such as this is not suitable for use in thevaginal or oral cavity for obvious safety concerns.

Locally applied heat (such as an abdominal heating patch) has also beenused to treat dysmenorrhea, or menstrual cramps, with demonstratedefficacy (Akin M D et al., Continuous low-level topical heat in thetreatment of dysmenorrhea., Obstet Gynecol 97: 3, 343-9, March, 2001).

U.S. Pat. No. 6,019,782 describes disposable thermal body pads with heatgeneration via an oxidation reaction intended for relieving menstrualpain when applied onto the abdominal skin. There is currently acommercial product in the U.S. market for dysmenorrhea treatment basedon abdominal heating, ThermaCare® Air-Activated Heatwraps, MenstrualCramp Relief patches manufactured by Procter & Gamble (Cincinnati,Ohio). However, there are no products or description of internallocalized heating to treat dysmenorrhea.

SUMMARY OF THE INVENTION

The compositions and methods of this invention relate to warminglubricant compositions that are non-toxic and non-irritating and thatcan be used as personal lubricants designed to come into contact withthe skin or mucosa. When mixed with water, the compositions of thisinvention increase in temperature or generate warmth. This has asoothing effect on the tissues to which these compositions are applied.

The compositions of this invention may be applied to the skin or mucousmembranes, preferably the vaginal or oral mucosa. The compositions ofthis invention are preferably substantially anhydrous and preferablycontain at least one polyhydric alcohol.

We theorize that, when the polyhydric alcohols contained in thecompositions of this invention come into contact with water or bodymoisture in humans, they react with the ambient water molecules to causean increase in temperature or generate warmth, thus having a soothingeffect on the tissues to which these compositions are applied.

Surprisingly, and contrary to the general belief that polyhydricalcohols in compositions are irritating to the mucosa, compositions ofthis invention containing such polyhydric alcohols have been found to benon-irritating. In fact, these compositions are very mild to the skinand mucous membranes. The compositions of this invention are soothingwhen applied to oral mucous membranes and may function to relieve minorirritation of the mouth and throat.

The combination of polyhydric alcohols in the compositions of thisinvention may also be used as a vehicle to solubilize otherwiseinsoluble drugs, including, but not limited to, antifungals,antibacterials, antivirals, analgesics, anti-inflammatory steroids,contraceptives, local anaesthetics, hormones and the like.

The compositions of this invention also preferably contain an insulatingagent which functions to preserve the temperature increase bymaintaining the heat within the composition after it has been applied tothe skin or mucosa. More preferably, honey may be utilized as aninsulating agent.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a graph depicting the % viable Epiderm cells vs Exposure Timeusing the composition of Example 1.

FIG. 2 is a graph depicting the % viable Epiderm cells vs Exposure Timeusing the composition of Example 2.

FIG. 3 is a graph depicting the % viable Epiderm cells vs Exposure Timeusing a State-of-the-Art non-irritating Product (K-Y Liquid@)

FIG. 4 is a graph depicting the % viable Epiderm cells vs Exposure Timeusing a State-of-the-Art warming Product (Prosensual®)

FIG. 5 is a graph comparing the Lubricity vs Time (Seconds) of thecomposition of Example 1 and three leading Personal Lubricants on themarket.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The compositions of this invention are substantially anhydrous,preferably containing less than about 20% water, more preferablycontaining less than about 5% water and, most preferably, containingless than about 3% water. Preferably, the compositions of this inventioncontain at least one polyhydric alochol, and more preferably, twopolyhydric alcohols. Preferably the polyhydric alcohol portion of thecompositions of this invention one or more polyhydric alcohols such asalkylene glycols and others selected from the following group: glycerin,propylene glycol, butylene glycol, hexalene glycol or polyethyleneglycol of various molecular weight and the like and/or combinationthereof. More preferably, the compositions of this invention contain apolyethylene glycol; most preferably, the polyethylene glycol may beselected from the following group: polyethylene glycol 400 orpolyethylene glycol 300. The compositions of this invention shouldcontain polyhydric alcohols in an amount from about 80% to about 98% byweight of the composition.

The compositions of this invention preferably also contain an insulatingagent. More preferably, the insulating agent should be honey or estersof isopropyl alcohol and saturated high molecular weight fatty acidssuch as myristic or palmitic acid, e.g., isopropyl myristate andisopropyl palmitate. The insulating agent should be present in thecompositions of this invention in an amount of from about 1% to about 5%by weight of the composition.

The compositions of this invention are unexpectedly self-preserving andmay not require a preservative. However, a preservative may be added toimpart an additional guarantee against microbial growth. A preservativemay be selected from preservatives known to those of skill in the art,including, but not limited to, one or more of the following:methylparaben, benzoic acid, sorbic acid, gallic acid, propylparaben orthe like. The preservative may be present in the compositions of thisinvention in an amount from about 0.01% to about 0.75% by weight of thecomposition.

The compositions of this invention may also preferably contain an ester.More preferably, the ester is a fatty acid ester. Most preferably, theester may include, but is not limited to: isopropyl stearate, isopropylmyristate, isopropyl palmitate, isopropyl laurate and the like. Mostpreferably, the ester is isopropyl myristate.

The compositions of this invention may contain one or more water-solublecellulose-derived polymers, gums, chitosans or the like. Such polymerscontribute to the viscosity and bioadhesiveness of the compositions ofthis invention. Preferably, such cellulose-derived polymers arehydroxyalkylcellulose polymers. More preferably, thehydroxyalkylcellulose polymer is hydroxypropylcellulose or Klucel®,available commercially from Hercules Incorporated, Wilmington, Del.

The polyhydric alcohols used in the compositions of this invention aretheorized to be useful as warming and heat-generating agents. Honeyfunctions as an insulating agent, protecting the compositions frombecoming too cold. The ester, preferably a fatty acid ester, functionsas an emollient and lubricant. The cellulose polymer is useful as aviscosity building agent. The compositions of this invention are uniquein that they lubricate, warm and soothe the tissues of the user,especially the oral and vaginal mucous membranes, without conveying afeeling of cold. Moreover, they are smooth and lubricating.

The compositions of this invention may be a liquid, a semi-solid, or asolid depending upon the particular intended use thereof. Thecompositions of this invention may also be formulated into soft or hardgelatin capsules, suppositories and impregnated into fabrics orpolymers.

The compositions of this invention may be used as personal lubricantswhich convey a feeling of warmth. The feeling of warmth generated by thecompositions of this invention is soothing to the skin or mucousmembranes where they are applied. The compositions of the invention alsopossess a sweet and pleasant taste, which is of particular benefit whenthese compositions are used orally.

The compositions of this invention may also be used as personalmoisturizers, which convey a feeling of warmth when applied to vaginalor oral mucosa.

The compositions of this invention may also be used as a vehicle todeliver medication or other treatment agents to the biomembranesincluding, but not limited to, hormones, antimicrobial or antifungalagents and the like. The antifungal agents is preferably an azole orimidazole, including but not limited to, miconazole, econazole,terconazole, saperconazole, itraconazole, butaconazole, clotrimazole,tioconazole, fluconazole and ketoconazole, vericonazole, fenticonazole,sertaconazole, posaconazole, bifonazole, oxiconazole, sulconazole,elubiol, vorconazole, isoconazole, flutrimazole and theirpharmaceutically acceptable salts and the like. Other antifungal agentsmay include an allylamine or one from other chemical families, includingbut not limited to, ternafine, naftifine, amorolfine, butenafine,ciclopirox, griseofulvin, undecyclenic acid, haloprogin, tolnaftate,nystatin, iodine, rilopirox, BAY 108888, purpuromycin and theirpharmaceutically acceptable salts.

Another embodiment of the invention are compositions for vulvovaginaluse containing one or more antibiotics. The antibiotic may be chosenfrom the group including, but not limited to, metronidazole,clindamycin, timidazole, ornidazole, secnidazole, refaximin,trospectomycin, purpuromycin and their pharmaceutically acceptable saltsand the like.

Another embodiment of the compositions of this invention includecompositions for vulvovaginal use containing one or more antiviralagents. Antiviral agents may preferably include, but are not limited to,immunomodulators, more preferably imiquimod, its derivatives, podofilox,podophyllin, interferon alpha, reticolos, cidofovir, nonoxynol-9 andtheir pharmaceutically acceptable salts and the like.

Still other embodiments of the compositions of this invention arecompositions that include one or more spermicides. The spermicides maypreferably include, but are not limited to, nonoxynol-9, octoxynol-9,dodecaethyleneglycol monolaurate, Laureth 10S, andMethoxypolyoxyethyleneglycol 550 Laurate and the like.

Still other embodiments of the compositions of this invention arecompositions containing antimicrobial agents. The antimicrobial agentsmay preferably include, but are not limited to, chlorohexidinegluconate, sodium polystyrene sulfonate, sodium cellulose sulfate,silver particles of micro- and sub-micrometer sizes, silver salts andother antibacterial agents known to the art.

Yet other embodiments of the compositions of this invention arecompositions that may include local anesthetics. The local anestheticsmay preferably include, but are not limited to, benzocaine, lidocaine,dibucaine, benzyl alcohol, camphor, resorcinol, menthol anddiphenylhydramine hydrochloride and the like.

Compositions of the invention may also include plant extracts such asaloe, witch hazel, chamomile, hydrogenated soy oil and colloidaloatmeal, vitamins such as vitamin A, D or E and corticosteroids such ashydrocortisone acetate.

Another embodiment of the compositions and methods of this inventioninclude compositions for vulvovaginal use containing one or morehormones for treating a decrease in estrogen secretion in the woman inneed of estrogen replacement such as women with vaginal atrophy. Thehormones may preferably include, but are not limited to, estrogenselected from the group consisting of estradiol, estradiol benzoate,estradiol cypionate, estradiol dipropionate, estradiol enanthate,conjugated estrogen, estriol, estrone, estrone sulfate, ethinylestradiol, estrofurate, quinestrol and mestranol.

Another embodiment of the compositions and methods of this inventioninclude compositions for vulvovaginal use containing one or moreanalgesics and/or nonsteroidal anti-inflammatory agents for treatingdysmenorrhea or mentrual cramping. The analgesics and nonsteroidalanti-inflammatory agents may preferably include, but are not limited to,aspirin, ibuprofen, indomethacin, phenylbutazone, bromfenac, fenamate,sulindac, nabumetone, ketorolac, and naproxen and the like.

Yet another embodiment of the compositions and methods of this inventioninclude compositions for oral and vulvovaginal use relates to a methodof enhancing the absorption of active agents from the appliedcompositions into the mucosal membrane by increasing the composition andmucosal tissue temperature via interaction of the polyhydric alcohols inthe compositions and moisture on the mucosa and subsequently releasedheat.

Yet another embodiment of the compositions of this invention includecompositions for vulvovaginal use relates to compositions and methodsfor preventing and/or treating dysmenorrhea by intravaginal warming orheating. Preferably, the composition heats the intravaginal area to atemperature preferably between about 37° C. and about 42° C., morepreferably between about 38° C. and about 41° C. The compositions ofinvention for use in such a method may optionally contain active agentssuch as analgesics and nonsteroidal anti-inflammatory agents fordysmenorrhea treatment. The composition of the invention may beadministered directly into the vagina by an applicator, or beimpregnated into vaginal devices such as tampon for intravaginalapplications.

The compositions of this invention may be manufactured as a coating of atampon, or dispersing throughout the absorbent tampon material, orenclosed inside as a core of a tampon. The compositions of thisinvention for the warming tampon for preventing and/or treatingdysmenorrhea preferably include a mixture of polyethylene glycols ofvarious molecular weights produced by The Dow Chemical Company (Midland,Mich.) under the trade names of CARBOWAX SENTRY PEG 300 NF, CARBOWAXSENTRY PEG 400 NF, CARBOWAX SENTRY PEG 600 NF, CARBOWAX SENTRY PEG 900NF, CARBOWAX SENTRY PEG 1000 NF, CARBOWAX SENTRY PEG 1450 NF, CARBOWAXSENTRY PEG 3500 NF, CARBOWAX SENTRY PEG 4000 NF, CARBOWAX SENTRY PEG4600 NF, and CARBOWAX SENTRY PEG 8000 NF. The compositions of thisinvention for dysmenorrhea prophylaxis and treatment may contain one ormore water-soluble cellulose-derived polymers and gums that form gelsaround the polyhydric alcohols such as glycerin, propylene glycol andpolyethylene glycols thus reducing the dissolution of the polyhydricalcohols, prolonging the solvation heat release, and regulating theelevated temperature in the preferred temperature range.

This invention also relates to a method of determining and comparingrelative amounts of irritation caused by particular sources using theEpiDerm™ Skin Model Assay as described in Example 1, such ascompositions applied to skin or mucosal cells. The following Example 1exemplifies the use of the method of this invention.

EXAMPLE 1 EpiDerm™ Skin Model Assay to Test Irritation of Lubricants

The method designated as EpiDerm™ Skin Model assay uses the epithelialcells derived from human skin as target cells and is commerciallyavailable from the MatTek Corporation. This assay is described inBerridge, M. V., et al. (1996) The Biochemical and Cellular Basis ofCell Proliferation Assays That Use Tetrazolium Salts. Biochemica 4:14-19. The test materials are applied directly to the epithelial cellculture surface. This test has not previously been used for determiningtoxicity of test materials. The toxicity of the test material isevaluated on the basis of relative tissue viability vs time. The actualTissue Viability is determined by NAD(P)H-dependent microsomal enzymereduction of MTT in control and test article treated cultures. Thenegative control used in this assay was deionized water and the positivecontrol was Triton X-100. The exposed cell cultures were incubated for4, 8, 16 and 24 hours and assayed for reduction of MTT. The data ispresented below in FIGS. 1 through 4 in the form of Relative Survival(relative MTT reduction) versus Exposure Time. Products with higherrelative survival rates are less toxic or less irritating while the oneswith lower survival rates are more toxic or irritating.

FIGS. 1 through 4 summarize the results of Epiderm Skin. Model Bioassay.The data is plotted as % Viable Cells vs the Exposure Time ranging from4 to 24 hours. FIGS. 1 and 2 represent the results for two compositionsof this invention, Composition 1 and Composition 2 respectively. FIG. 3represents the results of K-Y® Liquid that is an established personallubricant on the market. K-Y® Liquid is established as safe andnonirritating in animal and human testing and long-term human usehistory. Results for K-Y® Liquid showed 100.3% viable cells after 24hour of exposure (FIG. 3).

Example 1 of the invention (FIG. 1) and Example 2 of the invention (FIG.2) showed 91.1% and 96.9% viable cells respectively. FIG. 4 shows theresults of a warming composition known to the trade. This product usesplant materials like cinnamon, clove, ginger cloves and orange andothers for a warming sensation. The results show only 37.6% viable cellsafter 24 hours of exposure to this product. This indicates that suchcompositions will be irritating to the skin and mucous membranes.Compositions 1 and 2 of this invention, with 91.1% and 96.9% viablecells respectively, will be practically nonirritating. Positive control(Triton X-100) has only 22.4% viable cells at the 8-hour interval.

EXAMPLE 2 Generation Of Warmth

The compositions of this invention are anhydrous and contain one or morepolyhydric alcohol. When combined with water, the polyhydric alcoholsused in the compositions of this invention generate an increase intemperature that has a soothing effect on the tissues these compositionsare applied. In actual use the compositions of the invention interactwith the moisture of the vaginal or oral mucosa, thereby increasing thetemperature or generating feeling of warmth.

The “Generation of warmth” data summarized in Table 1 below, wasgenerated by mixing 20 ml of each of the ingredients in Composition 1and Composition 1 of this invention with 20 ml of water. The temperatureof the product and that of water were recorded before water was added tothe product. After the addition of water the mixture was mixed for twominutes and the actual temperature was recorded. Glycerin, PropyleneGlycol and Honey are the ingredients in Composition 1. It is clear fromTable 1. that when mixed with water the temperature of the mixture risesby 9.0° F. for Glycerin, 13.5° F. for Propylene Glycol, 17.0° F. forPolyethylene Glycol 400 and 12.5° F. for composition Example 1 of thisinvention. The calculated rise in temperature for Composition 1, basedon the rise in temperature and the % w/w quantity of each individualingredient in the composition was 10.875° F. The actual recordedtemperature rise for Composition 1. was 12.5° F. which is 1.625° F.higher than expected which indicates that there is an unexpectedincrease in temperature resulting from the combination of ingredients.GENERATION OF WARMTH (RISE IN TEMPERATURE ° F.) DATA BY MIXING EQUALQUANTITY OF EACH PRODUCT WITH WATER Rise in Average TemperatureTemperature Expected Actual (° F.) of the Product TemperatureTemperature Temperature (Expected Product Name (° F.) of Water (° F.) (°F.) (° F.) Minus Actual) Glycerin 69.0 71.0 70.0 79.0 9.0 AssayPropylene 72.4 71.0 71.7 85.2 13.5 Glycol Assay Honey 74.0 71.0 72.574.0 1.5 K-Y Warm ® 74.0 71.0 72.5 85.0 12.5 Isopropyl 75.0 74.1 74.575.2 0.7 Myristate Polysorbate 60 70.9 74.1 72.5 83.1 10.6 Polyethylene72.0 71.0 71.5 88.5 17.0 Glycol 400

Calculated Rise in Temperature: In order to determine the expected risein temperature from each composition, the percentage of each componentin such composition was multiplied by the temperature increase generatedby such component alone to obtain its expected contribution to thetemperature increase. These values were added together to calculate thetotal expected temperature rise. These values were then compared withthe actual temperature rise generated by each composition. For example,the calculated rise in temperature generated by the “K-Y Warm®”composition in the table above was found as follows and compared withthe actual temperature rise to determine the unexpectedly highergeneration of warmth of the composition: Propylene Glycol (50% of 13.5)= 6.75 Glycerin (45% of 9.0) = 4.05 Honey (5% of 1.5) = 0.075 Total10.875Difference: 12.5-10.875=1.625

EXAMPLE 3 Effect of Water Content on Generation of Warmth

On contact with moisture or water the heat of solution is responsiblefor the warming action of the compositions of this invention. There is aconcern that accidental contamination with water or prolonged exposureto excessive moisture, the warming capacity of the product may beadversely effected. According to this example, water was added tocompositions of this invention varying from about 1% to about 10% asoutlined in Table 2 below. The contents were thoroughly mixed and thesamples were allowed to stay at room temperature for 24 hour followingwhich the generation of warmth was determined as outlined in thefollowing paragraph. The results show that rise in temperature isproportionately decreased depending on the quantity of water added butthere is still an 8.5° F. increase in temperature at about 10% wateraddition.

The results of this example are set forth in Table 2 below. TABLE 2Effect Of Water Content On Generation Of Warmth For K-Y Warm ®. Rise inTemperature Temperature Average (° F.) of the Temperature ExpectedActual (Expected Sample of Water Temperature Temperature Minus ProductName (° F.) (° F.) (° F.) (° F.) Actual) No Water 73.80 70.00 71.9083.50 11.60 1% Water 73.90 70.00 71.95 82.20 10.25 2% Water 72.30 70.0071.95 81.70 9.85 3% Water 72.30 70.00 71.15 80.40 9.25 4% water 72.2070.00 71.10 80.70 9.60 5% Water 71.60 70.00 70.80 80.40 9.60 6% Water71.60 70.00 70.80 80.40 9.60 7% Water 71.50 70.00 70.75 80.20 9.45 8%Water 71.60 70.00 70.80 80.20 9.40 9% Water 70.90 70.00 70.45 79.50 9.0510% Water  70.50 70.00 70.25 79.00 8.50

EXAMPLE 4 Perception Of Warmth In Human Use

A human use study was conducted with 246 subjects. The data generated bythis study are summarized below in Table 2. The subjects were asked touse compositions of this invention. They were asked three questionsregarding the perception of warmth while using the product, as follows:

-   1. Does it warm on contact?-   2. Does it feel warm?-   3. Does it not feel cold?

The subjects were asked to register their response as Excellent, VeryGood, Good, Fair and Poor. The positive responses are summarized inTable 2. TABLE 3 PERCEPTION OF WARMTH IN HUMAN USE STUDY WITH 246 HUMANSUBJECTS USING COMPOSITION EXAMPLE 1 OF THE INVENTION QUESTION ASKEDPOSITIVE RESPONSE (%) Warms on Contact Excellent 25.12 Very Good 31.88Good 24.64 Total 81.64 Feels Warm Excellent 30.88 Very Good 28.92 Good25.98 Total 85.78 Does Not Feel Cold Excellent 54.37 Very Good 29.61Good 10.19 Total 94.53

As set forth in Table 3 above, 81.64% of the subjects registered apositive response that the product “warms on contact”, 85.78% subjectsfelt that the product “feels warm” while 94.53% subjects registered thatthe product “does not feel cold”.

EXAMPLE 4 Comparison Of Lubricity

Ahmad et al. in U.S. Pat. No. 6,139,848, which is hereby incorporatedherein by reference, describe a method to test lubricity of variouspersonal lubricants known to the trade. In the described test method,the lubricity of various marketed personal lubricants was determinedover a period of 300 seconds (5 minutes). The lubricity data disclosedin this patent indicates that K-Y Liquid® lubricant had a higherlubricity and was longer lasting during the 300 seconds test period thanthe competitive products. The lubricity data set forth in U.S. Pat. No.6,139,848 has a negative (−) sign during the “push” and positive (+)sign during the “pull” phase of the experiment. Compositions of thisinvention were tested using the lubricity test set foth in U.S. Pat. No.6,129,848. However, the test duration was successfully extended to 16minutes (960 seconds) and the data was treated to “curve-fit” toeliminate the negative (−) sign. The lubricity data for the composition1 of this invention is compared with the data for K-Y Liquid® in FIG. 5.The data indicate that Composition 1 of this invention has a higherlubricity as compare to K-Y Liquid® and that Composition 1 maintains thehigh lubricity for an extended period of 16 minutes (960 minutes) and istherefore longer lasting.

EXAMPLES 5-9 Compositions of the Invention

The following compositions of this invention were made as follows:first, propylene glycol and glycerin were mixed. A preservative and theinsulating agent were then added to the mixture in the same container.The mixture was then heated to from about 35° C. to about 45° C. tocompletely dissolve the preservative. The mixture was then cooled.

Composition 1: Propylene Glycol 50.00% Glycerin 45.00% Honey 5.00%

Composition 2: Propylene Glycol 50.00% Glycerin 20.00% IsopropylMyristate 27.00% Polysorbate 60 3.00%

Composition 3: Propylene Glycol 95.00% Honey 5.00%

Composition 4: Propylene Glycol 50.00% Glycerin 20.00% IsopropylMyristate 29.50% Klucel HF 0.50%

Composition 5: Propylene Glycol 99.50% Klucel HF 0.50%

Composition 6: Propylene Glycol 49.80% Glycerin 45.00% Honey 5.00%Preservative 0.20%

Composition 7: Miconazole Nitrate 2.00% Propylene Glycol 49.80% Glycerin43.00% Honey 5.00% Preservative 0.20%

Composition 8: Fluconazole 2.00% Propylene Glycol 49.80% Glycerin 43.00%Honey 5.00% Preservative 0.20%

Composition 9: Metronidazole 3.00% Propylene Glycol 49.80% Glycerin42.00% Honey 5.00% Preservative 0.20%

1. A substantially anhydrous lubricant composition comprising at leastone polyhydric alcohol and an insulating agent. 2-14. (canceled)
 15. Amethod of treating or preventing dysmenorrhea comprising applying acomposition comprising from about 80% to about 98% by weight polyhydricalcohol and less than about 20% by weight water intravaginally. 16-18.(canceled)
 19. A method of providing personal lubrication to a human'soral or vaginal mucosa during intercourse comprising applying to theoral or vaginal mucosa a composition comprising a substantiallyanhydrous lubricant composition which conveys a feeling of warmth uponapplication comprising at least one polyhydric alcohol.
 20. A method ofproviding personal lubrication to a human's vaginal mucosa duringintercourse comprising applying to the vaginal mucosa a compositioncomprising a substantially anhydrous lubricant composition which conveysa feeling of warmth upon application comprising at least one polyhydricalcohol.
 21. A method according to claim 19 wherein said polyhydricalcohol is selected from the group consisting of: glycerin, alkyleneglycol, polyethylene glycol and a mixture thereof.
 22. A methodaccording to claim 21 wherein said composition comprises from about 80%to about 98% by weight polyhydric alcohol
 23. A method according toclaim 28 wherein said composition comprises about 50% by weightpropylene glycol and about 45% by weight glycerin.